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Table 1 Summary of assessments, patient’s timeline

From: The place of S-ketamine in fibromyalgia treatment (ESKEFIB): study protocol for a prospective, single-center, double-blind, randomized, parallel-group, dose-escalation controlled trial

 

Study period

 

Enrolment

Allocation

Post-allocation

Close-out

Timepoint

T-2 weeks

t-2 weeks ➔ t0

T0

T+  2 weeks

T + 4 weeks

T+ 6 weeks

T + 9 weeks

T + 12 weeks

Enrolment:

 

Eligibility screen

X

       

Informed consent

X

       

Pregnancy test or electrocardiogram if needed

X

       

Allocation

 

X

      

Interventions:

 

Treatment administration

  

X

X

X

   

Follow-up consultation

     

X

X

X

Assessments:

 

Central Sensitization Inventory (CSI)

  

X

    

X

EQ5D-5 L

  

X

    

X

Hospital Anxiety and Depression Scale (HADS)

  

X

    

X

Brief Pain Inventory (BPI)

  

X

X

X

X

X

X

Patient Global Impression of Change (PGIC)

  

X

X

X

X

X

X

Adverse events

  

X

X

X

X

X

X

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Trials

ISSN: 1745-6215